In recent years, there has been a growing interest in point of care testing (PoCT) to provide health care personnel with timely information that facilitates informed decisions; to monitor spread of diseases and contaminants; and to make sophisticated capabilities available outside centralized laboratories such as in poor resource regions.
Despite global efforts to control the acquired immune deficiency syndrome (AIDS) pandemic, the human immunodeficiency virus (HIV) infection continues to spread relatively unabated in many parts of the world. The diagnosis of HIV infection at the point-of-care and in resource-poor settings poses considerable challenges due to the time delay between sample collection and diagnosis. The lack of a rapid, confirmed diagnosis leaves many individuals unaware of their condition and impedes tracking of patients by health providers.
To date, most efforts in this field have focused on detecting pathogens and antibodies in blood or plasma. In many cases, oral fluids contain the same pathogens and proteins as blood, but often at lower concentrations. Oral fluids, however, can be collected non-invasively by individuals with little training and without a need for special equipment. In addition, it may be is easier to collect oral fluid samples from children and the elderly than blood samples, collection of oral fluids is subject to fewer regulations compared with the collection of blood, and oral fluid collection reduces the risk of infection to the health care worker who collects the sample. However, since the oral fluid is a complex mixture of saliva secreted by parotid and other salivary glands, gingival cervicular fluid from the gingival crevice, and secretions from the mucous membranes, amplification of nucleic acids in oral fluid is challenging.
Accordingly, there is a need in the field for integrated diagnostic devices capable of performing nucleic acid testing at the point-of-care for detection of various disorders and diseases, including HIV.